CLINICAL PROTOCOL AND DATA MANAGEMENT Project Summary Clinical Protocol and Data Management (CPDM) at Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) provides support for the infrastructural elements of clinical research ? including finance, regulatory, data, and nursing management ? to promote WFBCCC science and its translation into the community, and promulgate National Cancer Institute and Cancer Center Support Grant objectives in clinical research operations. CPDM provides a broad range of management and quality control functions, including trial activation and monitoring, a centralized protocol document directory, a centralized database of protocol- specific data, data and safety monitoring activities that promote study participant safety, and assistance with complex regulatory issues. CPDM also provides high-quality services related to patient screening, obtaining informed consent, study enrollment, and safety reporting. The Specific Aims of CPDM are 1) to centrally manage and facilitate cancer clinical trials that prioritize patient safety and optimize participation, especially among underserved populations at WFBCCC; 2) perform regulatory and data management, data and safety reporting, and quality assurance functions of clinical trials conducted at WFBCCC; 3) provide protocol coordination throughout the trial lifecycle for trials conducted at WFBCCC; and 4) provide investigational drug monitoring and storage for clinical trials at WFBCCC. Since the previous competing review, CPDM has been consolidated into a fully centralized model, under the leadership of Stefan Grant, M.D., J.D., M.B.A., as the Clinical Research Medical Director. As part of this consolidation, Disease-Oriented Teams now have a formalized role, including procedures for reviewing clinical trial protocols. The Disease-Oriented Teams include faculty members from all four Programs and serve as the platform whereby new transdisciplinary clinical trial concepts are initially presented, discussed, prioritized, and developed. Dedicated research nurses and data managers are assigned to support each Disease-Oriented Team. Review of serious adverse events continues to be conducted by the Safety and Toxicity Review Committee, while Phase III trials (including WFBCCC National Cancer Institute Community Oncology Research Program trials) are also monitored by a separate Data Safety and Monitoring Board. The Office of Cancer Health Equity continues to make strides towards eliminating barriers to underserved populations seeking care at WFBCCC and facilitating their participation in clinical trials. These efforts have included a catchment area needs assessment, institutional policy and process changes, faculty and staff support, development of underserved patient programs, and community outreach to underserved populations.